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A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tradipitant High Dose | Experimental |
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| Tradipitant Low Dose | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tradipitant | Drug | Oral Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Vomiting Measured by Vomiting Assessment (VA) | Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Research Network, LLC | San Diego | California | 92103 | United States | ||
| Santa Monica Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42150111 | Derived | Nguyen T, Willett KC, Daly LR, Junker J, Andreescu O, Dima L. Tradipitant: A Novel Neurokinin-1 Receptor Antagonist for Motion Sickness. Am J Ther. 2026 May 14. doi: 10.1097/MJT.0000000000002147. Online ahead of print. | |
| 40103934 | Derived | Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tradipitant High Dose | Tradipitant: Oral Capsule |
| FG001 | Tradipitant Low Dose | Tradipitant: Oral Capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2022 |
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| Placebo |
| Drug |
Oral Capsule |
|
| Santa Monica |
| California |
| 90025 |
| United States |
| Gulfcoast Psychiatric Associates | Fort Myers | Florida | 33912 | United States |
| Harmony Clinical Research | North Miami Beach | Florida | 33162 | United States |
| Avita Clinical Research | Tampa | Florida | 33613 | United States |
| Beacon Clinical Research | Quincy | Massachusetts | 02169 | United States |
| Manhattan Medical Research | New York | New York | 10016 | United States |
| FG002 |
| Placebo |
Placebo: Oral Capsule |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tradipitant High Dose | Tradipitant: Oral Capsule |
| BG001 | Tradipitant Low Dose | Tradipitant: Oral Capsule |
| BG002 | Placebo | Placebo: Oral Capsule |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Population does not include withdrawn subjects | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevention of Vomiting Measured by Vomiting Assessment (VA) | Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited. | Posted | Count of Participants | Participants | 1 day |
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Adverse Events were recorded from time of randomization until the end of study visit, up to 7 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tradipitant High Dose | Tradipitant: Oral Capsule | 0 | 120 | 0 | 120 | 26 | 120 |
| EG001 | Tradipitant Low Dose | Tradipitant: Oral Capsule | 0 | 123 | 0 | 123 | 20 | 123 |
| EG002 | Placebo | Placebo: Oral Capsule | 0 | 122 | 0 | 122 | 4 | 122 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | 2027343400 | clinicaltrials@vandapharma.com |
| Apr 19, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009041 | Motion Sickness |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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